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RecruitingPhase 2

ALTO-207 in Adults With Treatment-resistant Depression (TRD)

Alto Neuroscience · NCT07553637

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
178
US sites recruiting
40
Study start
May 20, 2026
Record last updated
October 26, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The purpose of this trial is to measure depressive symptoms following treatment with ALTO-207 compared with placebo in participants with TRD.

Being studied: ALTO-207; Placebo

Conditions: Treatment-resistant Depression (TRD)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Male and female participants, ages 18 to 75 years, inclusive, at the time of signing the ICF.
  • Prior diagnosis of MDD without psychotic symptoms (in the current episode) and have confirmatory diagnosis of current MDD (moderate to severe).
  • Failure to respond (\<50% improvement) to at least 2-5 antidepressant treatments (including the current treatment)
  • Currently taking a stable dose of at least 1 but no more than 2 oral antidepressants at baseline

Exclusion Criteria

  • Evidence of unstable medical condition
  • Concurrent use of any prohibited medications or substance use disorder
  • Diagnosed bipolar disorder or a psychotic disorder or symptoms
  • Significant current PTSD symptoms or history of PTSD
  • Clinically significant current impulse control difficulties
  • Has a history of hypersensitivity or allergic reaction to ALTO-207 or any of its components/excipients
  • Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device

Recruiting US locations

Study contacts (from the official record)

  • Alto Neuroscience · 510-512-3668 · clinical@altoneuroscience.com
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ALTO-207 in Adults With Treatment-resistant Depression (TRD) (NCT07553637) | Bored Studies